Last month Allergan voluntarily opens in a new windowrecalled all BIOCELL textured breast implants at the request of the FDA. While this move may help reduce instances of BIA-ALCL, the announcement has led to some confusion and unnecessary stress among patients nationwide. To help patients better understand their options, I have highlighted the main points to consider in light of this recent news.
Only Allergan’s BIOCELL Textured Implants Have Been Recalled
Smooth and Microcell breast implants manufactured by Allergan have not been directly linked with an increased risk of developing BIA-ALCL and will remain on the market. The recalled BIOCELL textured breast implants include:
- Natrelle Saline breast implants
- Natrelle Silicone breast implants
- Natrelle Inspira Silicone breast implants
- Natrelle Highly Cohesive Anatomically Shaped Silicone breast implants
This Recall Only Impacts Future BIOCELL Sales and Implant Surgeries
Existing patients with textured implants but without symptoms are not being encouraged to have their implants removed. The FDA has asked consumers and physicians to avoid the continued use of BIOCELL textured breast implants as several suitable alternatives are available.
BIA-ALCL Is Very Rare
Currently, there are only opens in a new window573 unique cases of confirmed BIA-ALCL and 33 fatalities worldwide among an estimated 10 million patients globally with implants. BIA-ALCL is therefore extremely rare, even among patients with textured implants.
Most Confirmed BIA-ALCL Cases Were Linked to BIOCELL Implants
This correlation led researchers to believe that it is the BIOCELL texturing process and not the existence of the breast implant itself which may create the environment for BIA-ALCL to develop in some women. In agreement with the FDA, we do not recommend that patients with textured breast implants have their opens in a new windowimplants removed as long as they are not experiencing any symptoms and are pleased with their appearance. This is due to the fact that any surgery carries its own risks, and the overall risk of developing BIA-ALCL is extremely low. If you still have questions or concerns, we encourage patients to visit their board certified plastic surgeon to learn more.
If you have experienced unexplained swelling, pain, or changes in your breasts, please contact your primary care physician or board-certified plastic surgeon to be evaluated and determine if there is a problem that requires attention.
John D. Smoot, MD FACS is the Medical Director of La Jolla Cosmetic Surgery Centre located on the Scripps Memorial Hospital Campus in La Jolla, California. During his 30 years as a Board Certified Plastic Surgeon in the San Diego area, Dr. Smoot has earned a reputation for providing excellent care and beautiful cosmetic surgery results.